Sr. Manufacturing Engineer

Responsibilities:

• Assess the impact of IT reports, applications, software, and hardware changes on manufacturing processes and equipment.
  

• Plan, execute, and document Computer Systems Validation (CSV) activities, including validation protocols, execution, and final reports.
  

• Implement and support manufacturing procedures and documentation changes.
  

• Inspect machinery, equipment, and tools to verify operational efficiency and performance.
  

• Investigate equipment and process deficiencies and initiate corrective actions to ensure product quality.
  

• Ensure manufacturing processes and procedures comply with regulatory and quality system requirements.
  

• Deliver and manage assigned engineering projects in collaboration with cross-functional teams.
  

• Contribute to department and work group objectives through effective collaboration and stakeholder engagement.
  

• Provide technical guidance, coaching, and review of work for lower-level engineers or specialists.
  

• Communicate with senior internal stakeholders and external vendors to exchange technical information and influence decision-making.
  

Requirements

Requirements:

• Bachelor’s Degree in Engineering required.
  

• Minimum 4 years of relevant manufacturing engineering experience, or
  

• Minimum 2 years of experience with an advanced engineering degree.
  

• Demonstrated experience performing Computer Systems Validation (CSV) in a regulated environment.
  

• Experience assessing and managing manufacturing and IT-related system changes.
  

• Proven experience leading technical initiatives or projects.
  

• Strong understanding of regulatory compliance requirements.
  

• Ability to manage complex technical issues involving multiple systems or processes.
  

• Effective communication skills for interaction with internal and external stakeholders.
  

Skills:

• Computer Systems Validation (CSV)
  

• IT Systems Knowledge (manufacturing-related)
  

• Manufacturing Engineering
  

• Equipment Performance Evaluation
  

• Process and Procedure Changes
  

• Regulatory Compliance (cGMP / Quality Systems)
  

• Technical Leadership
  

• Project Management
  

• Root Cause Analysis & Corrective Actions
  

• Cross-Functional Collaboration
  

• Technical Documentation
  

• Stakeholder Communication
  

Work Schedule & Availability:

• Full-time, onsite position.
  
• Availability to work extended shifts (8–12 hours).
  
• Availability to work weekends and holidays as required.
  
• Availability to work 1st and/or 2nd shift (primarily 1st shift).